TheraRadar
Data updated: May 26, 2026

BENDEKA (bendamustine hydrochloride)

Trial Activity: Stable 9 active trials
Oncology Approved 2015-12-07

Bendeka is an alkylating medication used for patients with chronic lymphocytic leukemia. It also helps patients with indolent B-cell non-Hodgkin lymphoma that has worsened during or within six months of receiving rituximab-based therapy. This drug provides a treatment option for these specific blood cancers, though its effectiveness compared to first-line therapies other than chlorambucil is not fully established.

Source: FDA Label • EAGLE PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How BENDEKA Works

This drug works by forming covalent bonds with DNA, which creates interstrand crosslinks that lead to cell death. As a bifunctional alkylating agent, it targets both resting and dividing cells by creating electrophilic groups that bind to specific parts of the cell's genetic material.

Source: FDA Label

Development Insights

National Cancer Institute (NCI) conducting 6 trials (15%)
128 indications explored (Broad Platform)
→ recurrent mantle cell lymphoma (7 trials)
→ recurrent adult diffuse large cell lymphoma (6 trials)
→ recurrent grade 1 follicular lymphoma (6 trials)
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2015-12-07
Patent Cliff
2033

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Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

EAGLE PHARMS
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE

BENDEKA Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
11 FDA actions from 2015 to 2024
Jan 2024 SUPPL
Label · Labeling
FDA Letter Label
Oct 2021 SUPPL
Label · Labeling
FDA Letter Label
Nov 2019 SUPPL
Label · Labeling
FDA Letter Label

What BENDEKA Treats

2 indications

BENDEKA is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma
Source: FDA Label

BENDEKA Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IDELALISIB
NATCO
2026 3 indic.
PLERIXAFOR
GLAND
2023 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in BENDEKA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BENDEKA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

Drugs Similar to BENDEKA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BELRAPZO
BENDAMUSTINE HYDROCHLORIDE
2 shared
EAGLE PHARMS
Shared indications:
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
IDELALISIB
IDELALISIB
2 shared
NATCO
Shared indications:
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
TREANDA
BENDAMUSTINE HYDROCHLORIDE
2 shared
CEPHALON
Shared indications:
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
View all 20 similar drugs Pro
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Clinical Trial Registry

40 trials
Trial Sponsor ID Phase Status Title
NCT03269669 NCI-2017-00009 NCI-2017-00009, S1608 Ph 2 active not recruiting Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
NCT04115631 EA4181 NCI-2019-05536, EA4181 Ph 2 active not recruiting A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT01886872 results posted NCI-2013-01220 NCI-2013-01220, ALLIANCE A041202 Ph 3 active not recruiting Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
NCT01479842 OSU-10052 NCI-2011-03293 Ph 1 active not recruiting Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma
NCT01286272 results posted NCI-2011-02625 NCI-2011-02625, CALGB-50904 Ph 2 completed Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma
NCT02153580 13351 NCI-2014-01168, 114025 Ph 1 active not recruiting Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
NCT02224729 results posted 14D.300 2014-025, JT 6192 Ph 2 completed Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT04587687 UCDCC#284 NCI-2020-06645, UCDCC#284 Ph 2 recruiting Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
NCT04943302 00001665 Ph 2 withdrawn Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis
NCT04943757 PTBCy 05/21-n Ph 2 completed Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies
NCT01664910 results posted 2012-0265 NCI-2012-02072, 2012-0265 Ph 1, Ph 2 completed CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies
NCT06477549 14/24-n Ph 2 recruiting BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
NCT04942730 FluBuBe 06/21-n Ph 2 completed Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)
NCT04510636 KEsTREL-01 CAPCR 20-5231 Ph 2 recruiting Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
NCT02168140 IRB00028206 NCI-2014-01281, CCCWFU 28314 Ph 1 completed CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
NCT01596621 results posted C18083/3076 Ph 3 completed A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment
NCT01535924 results posted OSU-11015 NCI-2012-00022 Ph 1, Ph 2 completed Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
NCT01412879 results posted CDR0000707601 S1106, U10CA032102 Ph 2 completed S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT03259529 BeGeRN DLBCL BeGeRN 1/2 Ph 1, Ph 2 completed Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL
NCT04913103 CLSGMCLPOLA CLSG-MCL-POLA Ph 2 not yet recruiting Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL
NCT02095834 2012-0162 NCI-2014-00884, 2012-0162 Ph 1 completed Carfilzomib, Bendamustine Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT03343652 NB001 10/17-n Ph 1, Ph 2 completed A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
NCT01611090 results posted CR100840 PCI-32765CLL3001, 2012-000600-15 Ph 3 completed A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01049945 results posted MMRC-020-021 NCI-2009-01535, MMRC-020-021 Ph 1, Ph 2 completed Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
NCT01326702 results posted NCI-2011-02583 NCI-2011-02583, CDR0000697580 Ph 1, Ph 2 completed Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors
NCT00987493 SAKK 38/08 SWS-SAKK-38/08, 2009-012559-67 Ph 1, Ph 2 completed Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma
NCT02240719 637004 637004, CRAD001NUS235T Ph 1 completed Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer
NCT01165112 TREC results posted PSOC 2502 NCI-2010-00907, PSOC 2502 Ph 1, Ph 2 completed Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
NCT02168907 IRB00027759 NCI-2014-01280, CCCWFU 28114 Ph 1 terminated CPI-613, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
NCT02420210 results posted IRB14-1120 NCI-2015-00355, IRB14-1120 Ph 2 terminated Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma
NCT01369849 results posted NCI-2011-02675 NCI-2011-02675, CDR0000701372 Ph 1, Ph 2 completed Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01141725 results posted 2413.00 NCI-2010-01253, K12CA076930 Ph 1, Ph 2 completed Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS
NCT00823797 results posted 6803 NCI-2010-00714, 6803 Ph 2 completed Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
NCT01110135 results posted 7176 NCI-2010-00509 Ph 2 completed Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma
NCT00939328 S0902 S0902, U10CA032102 Ph 2 withdrawn S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment
NCT00984542 results posted VICC THO 0920 P30CA068485, VU-VICC-THO-0920 Ph 2 completed Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
NCT00947388 CASE1907 NCI-2010-00272 Ph 1 terminated Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
NCT01238146 NCI-2011-02536 OSU-10040, U01CA076576 Ph 1, Ph 2 withdrawn Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
NCT01108341 results posted C18083/2048 2009-016725-34 Ph 2 completed Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
NCT07593482 FC-BALANCE SCI-003_FC-BALANCE 2026-525792-36-00, U1111-1335-8513 Ph 2 not yet recruiting Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BENDEKA FDA Label Details

Indications & Usage

FDA Label (PDF)

BENDEKA is indicated for the treatment of Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma.

View full patent landscape →
20 OB patents · 4 families · 223 international docs across 31 countries

BENDEKA Patents & Exclusivity

Latest Patent: Mar 2033

Patents (20 active)

US9144568 Expires Mar 15, 2033
US10052385 Expires Mar 15, 2033
US9597399 Expires Mar 15, 2033
US9034908 Expires Mar 15, 2033
US9597397 Expires Mar 15, 2033
US9572887 Expires Mar 15, 2033
US9579384 Expires Mar 15, 2033
US9000021 Expires Mar 15, 2033
US9597398 Expires Mar 15, 2033
US8609707 Expires Aug 11, 2031
US9572797 Expires Jan 28, 2031
US9572796 Expires Jan 28, 2031
US12350257 Expires Jan 28, 2031
US11103483 Expires Jan 28, 2031
US11844783 Expires Jan 28, 2031
US11872214 Expires Jan 28, 2031
US12138248 Expires Jan 28, 2031
US10010533 Expires Jan 28, 2031
US9265831 Expires Jan 28, 2031
US8791270 Expires Jan 12, 2026
Source: FDA Orange Book

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Deep insights for BENDEKA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 32 active patents

Trial Analysis

  • • 39 total trials
  • • Stage: Stable

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA208194 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment